efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee

Conditions: Osteoarthritis of Knee

Summary: to compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.

Eligibility criteria:
inclusion criteria: * willing and able to read and understand informed consent and questionnaires in english. * adults of either gender age 35-75 years, in general good health. * established x-ray diagnosis of osteoarthritis of at least one knee. * taken nsaid including cox-2 (cyclo-oxygenase-2) inhibitor in full therapeutic dose for at least one month prior to screening. * able and will to discontinue osteoarthritis medications until flare criteria met. * bmi\</= 45 * subjects must rate target knee at least 5 out of 10 on discomfort vas (visual analogue scale) at baseline visit. * have an increase of at least 15mm on a 100mm pain vas (visual analogue scale) from screening to baseline visit. * must use acceptable birth control if female. * screening fecal occult must be negative. * able to attend all required visits * physical therapy is allowed as long as the type and frequency remains unchanged for the duration of the study. exclusion criteria: * refusal to sign consent. * inability to attend all clinic visits * grade 0-1 k-l changes in both knees or grade 4 k-l changes in either knee on standing a/p radiograph * pregnant or lactating women * history of serious cardio-vascular disease. * recurrent arrythmias, except paroxysmal tachycardia, cardiomyopathy, myocardial infarct within one year of screening. * history of chronic esophageal, gastric or duodenal disease * history of upper gi bleeding within the past 2 years. * any gi disorder associated with malabsorption * any musculo-skeletal or neurological condition that results in pain or gait disturbance that might confound evaluation of target knee. * uncontrolled diabetes mellitus * history of bleeding disorder or concurrent use of coumadin or any agent used to reduce blood clotting or platelet adhesiveness. * concurrent use of any anti-arthritic medication, including corticosteroids regardless of the reason for use. (low dose aspirin for cardioprotection is allowed) * history of chronic renal disease with creatinine \>2.0 or nephrotic syndrome with 24 hour protein excretion \>1000mg. * intra-articular injection of any hyaluronic acid preparation in the target knee joint within 4 months of baseline visit. * intra-articular injection of a corticosteroid in the target knee joint within 2 months of the baseline visit. * bmi\>45 * history of allergic reaction to flavonoid or flavan containing foods or products (example: red wine, colored fruits and vegetable, brazil nuts, tea, natto) * history of allergy to aspirin, naproxen or other nsaid * history of substance abuse including alcohol, or any psychiatric condition that may impair the subject's ability to comply with the study requirements. * any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study. * participation in another clinical trial within 30 days or 7 half lives of the study agent, whichever is longer, of the screening visit.